Clearance Summary
Powdered Free Sterile Natural Rubber Latex Surgical Gloves received FDA 510(k) clearance under submission number K230832, sponsored by The Egyptian Company For Medical & Electronic Industries. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2023-08-16.
- Submission: K230832
- Applicant / Sponsor: The Egyptian Company For Medical & Electronic Industries
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2023-08-16
Classification & Regulation
This clearance is catalogued under FDA product code KGO and 21 CFR 878.4460, within the General, Plastic Surgery review panel as a Class I device.